Position:- :- Serialization Execution System (Validation)
Location: - Indianapolis, IN
JD:-
SCADA, PLC, Systech, Serialization, Automation, Packaging line and vision systems
Provide tier2 support to the Serialization Execution System. Assist existing teams in software qualification and validation activities and further assist the Serialization support team in managing serialized lines. Develop a global, repeatable, and logical process to effectively resolve any issues arising from the installation and subsequent operation of Serialization hardware components in packaging operations. Providing updates to customers regarding ongoing issues. Maintain and update procedures as required. Updating engineering, user requirements, and design documents for any changes made to the serialization system. Formal investigation of support issues, communication with impacted stakeholders and vendors, resolution/closure of the problem, and updating appropriate knowledge management records.
Experience of Process Automation Systems Experience in Systech suite of products (Systech Guardian, Advisor and Sentri) Track & Trace, Serialization & Brand Protection - Systech Experience working with Systech product team and process automation and engineering teams. Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Planning (Project Validation Plan or Validation Master Plan), User/Functional Requirements, Design Specifications, Design Qualification (DQ), Commissioning (FAT, SAT, Startup), Qualification Test Protocols (IQ/OQ/PQ), Process Validation (PV). Experience in pharma packaging processes and packaging equipment custom software Strong problem-solving and strong analytical skills are essential. Ability to troubleshoot issues and provide timely resolution. Excellent analytical, organizational, team, and project management and documentation skills Excellent written verbal communication skills Strong understanding of software development lifecycle and maintenance plans Experience working in a support role in a flexible schedule Experience in providing tier2 support in 24/7 pharmaceutical manufacturing and packaging operations Worked in direct support of and along with the maintenance staff to maintain both complex and straightforward systems used in packaging operations Experience with Systems Management (disaster recovery, problem management, incident management, change management etc).